Multiple sclerosis (MS) is a neurodegenerative disease that affects more than 2 million people globally and is associated with poor quality of life. MS involves an aberrant immune system attacking the central nervous system, and disease-modifying drugs are thought to act by suppressing or modulating the immune system.

Cladribine tablets are the first oral therapy with a short-course, limited cycle dosing schedule approved for patients with relapsing forms of MS (RMS). In clinical studies, cladribine tablets have demonstrated efficacy in patients across the RMS spectrum.

The safety profile of cladribine tablets monotherapy at the recommended dosage of 3.5 mg/kg includes data from > 3700 patient-years of cladribine exposure at this dose, and from > 2200 patient-years of placebo exposure in clinical trials. The most common adverse events reported with cladribine tablets include headaches and lymphopenia. Additional adverse events examined include malignancy and infections.